Insights On Quality Assurance

1. When Clean Is Critical—Understanding Parameters And Definitions Of Clean 11/15/2019

   Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

2. Business Continuity Program: Maintain Operations During Crises 5/5/2020

   Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

3. A Guide To Weigh Cell Technologies For Food And Pharma Industries 7/28/2020

   For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. The latest and greatest catchweighers and checkweighers incorporate weigh cells featuring Electro-Magnetic Force Restoration, or EMFR. In addition, combining EMFR with AVC (Active Vibration Compensation) enables accurate product weight measurements.

4. Building Trust – Engineering To Quality & Validation 12/21/2020

   Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Quality is focused on the identification, mitigation, control of risks to product quality and verification of the process risk control strategy. Historically, the Quality unit has not had sufficient trust in Good Engineering Practices (GEPs) to facilitate their effective use in risk-based C&Q. Why has that trust been missing, and how can it be built?

5. Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle 6/13/2019

   Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.

6. Why Don’t OEM Recommendations Work For Maintenance? 12/22/2020

   During the Design, Build, Test phase of an asset’s lifecycle, many organizations will choose to start with maintenance and spare parts recommendations from the vendors and manufacturers of the equipment. Nearly without fail, a few months or years pass, and the asset begins to fail unexpectedly. Why does this happen, and how can we make this stop?

7. An Introduction To Product Inspection And Tracking Solutions For The Cannabis Industry 7/28/2020

   As the cannabis market grows, so does regulatory agency cannabis tracking requirements. Let's look at some of the cannabis hardware and software packaging solutions that provide increased profitability and reporting accuracy.

8. Managing Risks With Potent Pharmaceutical Products 7/2/2019

   Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

9. Formulation Development: Determining Oxygen Sensitivity 6/3/2020

   Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

10. Quality Assurance And Your CDMO 8/27/2019

    The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.